CETEC 10MG FILM-COATED TABLETS

PDF Transcript

health essentialsTM
Hayfever and Allergy Relief 10mg
Tablets

•

(Cetirizine hydrochloride)

•

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
• Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist have
told you.
• Keep the leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• You must contact a doctor if your symptoms
worsen or do not improve after few days.
What is in this leaflet:
1. What Hayfever and Allergy Relief film-coated
tablets are and what they are used for
2. What you need to know before you take
Hayfever and Allergy Relief film-coated tablets
3. How to take Hayfever and Allergy Relief
film-coated tablets
4. Possible side effects
5. How to store Hayfever and Allergy Relief
film-coated tablets
6. Contents of the pack and other information

1. What Hayfever and Allergy Relief
film-coated tablets are and what they
are used for
• The name of your medicine is Hayfever and
Allergy Relief 10mg film-coated tablets, referred

SAME SIZE ARTWORK

•

•

to as Hayfever and Allergy Relief film-coated
tablets in this leaflet.
The active ingredient, Cetirizine hydrochloride
belongs to a group of medicines called
antihistamines.
It blocks the effects of a substance called
histamine which occurs naturally in the body.
Histamine is involved in allergic reactions.
Hayfever and Allergy Relief film-coated tablets are
used to treat people who have hay fever (seasonal
allergic rhinitis), year round allergies such as dust
or pet allergies (perennial allergic rhinitis) and
urticaria (swelling, redness and itchiness of the
skin).
Hayfever and Allergy Relief film-coated tablets also
relieve the unpleasant symptoms and discomfort
associated with these conditions, such as sneezing,
irritated, runny and blocked up nose, itchy, red and
watering eyes and skin rashes.

2. What you need to know before you
take Hayfever and Allergy Relief
film-coated tablets
Do not take if you:
• have severe kidney failure (creatinine clearance
less than 10 ml/min) and are on dialysis
• are known to be allergic (hypersensitive) to
cetirizine hydrochloride or any of the other
ingredients (listed in section 6) or to hydroxyzine
or to piperazine derivatives (closely related active
substances of other medicines)
Warnings and precautions
Talk to your doctor or pharmacist before taking
Hayfever and Allergy Relief film-coated tablets if:

• you have kidney problems
• you suffer from epilepsy or at risk of convulsions
• you have predisposition factors of urinary
retention (e.g.. spinal cord lesion, prostatic
hyperplasia) as cetirizine increases the risk of
urinary retention.
• you want to use for children less than 6 years of
age
Other medicines and Hayfever and Allergy Relief
film-coated tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
• If you are pregnant or likely to become pregnant,
ask your doctor or pharmacist for advice before
taking any medicine.
• Do NOT take this medicine during breast feeding
because cetirizine passes into breast milk.
Hayfever and Allergy Relief film-coated tablets
with food, drink and alcohol
It is recommended to avoid alcohol while taking this
medicine
Driving and using machines
Some people have reported that they feel drowsy or
dizzy while they are taking Hayfever and Allergy
Relief film-coated tablets. If you are affected do not
drive or use machines.
Hayfever and Allergy Relief film-coated tablets
contain Lactose
• If you have been previously told by your doctor
that you have intolerance to some sugars (such as
lactose), contact your doctor before taking this
medicine.

3. How to take Hayfever and Allergy
Relief film-coated tablets
• Take the tablet with a glass of water
• Do not take more than one tablet each day
• If you do not feel better within a few days, consult
your doctor
• The tablet can be divided into equal halves.
The usual doses are as follows:
Adults and children aged 12 years and over:
Take one tablet daily. If the tablets make you feel
drowsy or dizzy, taking half a tablet twice a day may
be better than taking one tablet once a day.
Children aged 6 to 12:
Take half a tablet twice a day. Hayfever and Allergy
Relief film-coated tablets are not suitable for children
under 6.
If you have kidney problems you should talk to your
doctor or pharmacist for advice before taking these
tablets as a lower dose may be required.
If you take more tablets than you should
If you accidentally take too many tablets, tell your
doctor immediately or contact your nearest Hospital
Casualty/Accident & Emergency department even if
there are no signs of discomfort. Take your medicine
in its original packaging with you in order to enable
the doctor to identify your medication easily.
If you forget to take a tablet
If you forget to take a tablet, you should take one as
soon as you remember, but wait at least 24 hours
before taking your next tablet.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR
A FORGOTTEN DOSE.

IXXXXX

PATIENT LEAFLET: INFORMATION FOR THE USER

SAME SIZE ARTWORK
240 x 120 mm
Back

• Oedema (generalised swelling due to water
retention)
• Abnormal liver function test results (your doctor will
know what to do)
• Convulsions, movement disorders
• Increased weight
• Aggression, confusion, depression, hallucination
(hearing or seeing things), sleeplessness
• Urticaria (hives)
Very rare side effects (may affect up to 1 in 10,000
people)
• Blurred vision, difficulty focussing
• Rotation of the eyes
• Unusual bleeding or bruising
• Bad taste in the mouth
• Tremor, tics
• Involuntary movements and/or jerking of the limbs
• Muscle spasms in the neck and shoulders
• Swelling of the skin particularly around the face
• Fainting
• A recurring rash
• Bed wetting, pain and/or difficulty passing water
Not known side effects (frequency cannot be
estimated from the available data)
• Increased appetite
• Inflammation of liver (hepatitis)
• Vertigo
• Urinary retention
Some cases of memory loss and/or impairment have
also been reported. In very rare cases people have
thought about committing suicide and if you feel this
way then stop taking the tablets and see your doctor

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly via the Yellow card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on
the safety of this medicine

5. How to store Hayfever and Allergy
Relief film-coated tablets
• Keep out of the sight and reach of children
• Do not store above 250C. Store in the original
package.
• Do not use the tablets after the expiry date
shown on the carton or label. The expiry date refers
to the last day of that month.
• Do not throw away any medicines via wasterwater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

white to off white capsule shaped film coated tablets
with a breakline and ‘B’ and ‘L’ embossed on either
side of the breakline and ‘10’ embossed on the
other side.
• Hayfever and Allergy Relief film-coated tablets are
available in packs of 7, 14 and 30 tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1EG,
United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
health essentialsTM Hayfever and Allergy Relief
10mg film-coated tablets; PL 17907/0046
This leaflet was last revised in August 2014
To request a copy of this leaflet in Braille, large print
or audio format, please contact the licence holder at
the address (or telephone, fax, email) above.

V3 29-08-2014 D1

IXXXXX

4. Possible Side Effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effect is very rare, but you must
stop taking the tablets and speak to your doctor
straight away if you notice these symptoms:
• A severe allergic reaction including rash, itchiness
and fever, swollen throat, face, eyelids or lips. This
reaction may start soon after you first take the
medicine, or it might start later.
The following side effects have also been
reported:
Common side effects (may affect up to 1 in 10
people)
• Tiredness, feeling sleepy
• Pain in the abdomen
• Headache
• Dizziness
• Dry mouth
• Sore throat
• Nausea
• Cold-like symptoms of the nose (children only)
• Diarrhoea (children only)
Uncommon side effects (may affect up to 1 in 100
people)
• Itching and rash
• Tingling in the hands and feet
• Diarrhoea
• Feeling agitated
• Feeling weak or generally unwell
Rare side effects (may affect up to 1 in 1,000
people)
• Fast heart beat

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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